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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Sponsored Webcast: Negotiation is Another Word for Problem Solving

*** On-line Registration is closed. You can still register by phone by contacting the RAPS Solutions Center at +1 301 770
2920, ext. 200.***

23 October 2018

12:00 – 1:30 pm EDT

Based on research and conferences conducted by the Harvard Negotiation Project, this webcast will cover techniques and tactics of principled negotiation, illustrating how to achieve great results while being decent and fair with colleagues or health authorities. Principled negotiation requires discipline and tact - it pushes hard on the merits of proposals while preserving relationships. It employs no tricks or posturing; negotiation is channeled into a problem-solving conversation.

Being a skilled negotiator is particularly important for regulatory professionals, interacting with a wide variety of teams, divisions, health authorities, etc – all with different objectives and concerns. Improve your negotiation skills in this webcast by learning to probe the interests of the other party, acknowledge feelings, listen actively, ask revealing questions, seek options for mutual gain and understand that the most powerful interests are basic human needs.

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Anyone that needs to use negotiations to influence without direct management authority

Anyone tasked to facilitate discussion and agreement between differing parties

Speaker

Frank Carillo, ceo, ECG

Frank originally learned negotiation principles and techniques at the Wharton School of Business. Throughout his career, he’s demonstrated how communication strategy empowers people to build the explanations and advocacy necessary. Frank has worked with clients who present new drug applications to the Food and Drug Administration’s Advisory Committee meetings for approval and commercial release. Under his direction, ECG has supported over 165 FDA AdComms, including numerous first-in-class approvals across a wide variety of therapeutic areas and many Marketing Authorization Application approvals (including Oral Explanations and Scientific Advisory Groups) with the European Medicines Agency.